Qualification Documentation Specialist – Lab Compliance

CBRE; Indianapolis (IN); On-site; USD 65,000 - 90,000; Full time

Job summary

CBRE's Full Spectrum Lab Services unit seeks an experienced professional to support pharmaceutical research and development environments. You will manage instrument qualification activities, update procedures, and help ensure inspection readiness in highly regulated settings.

Coordinate qualification tasks, author and update qualification documents, and support data archiving and change controls. You will verify IQ/OQ/PQ protocols, ensure documentation accuracy, and help drive compliant outcomes

Qualifications

• High School Diploma, GED, or trade school diploma with 5-8 years of related experience.
• Knowledge of setup, operation, and maintenance of HPLC/UPLC instrumentation.
• Ability to lift 50 lbs and perform physical tasks as required.
• Innovative mindset to develop methods beyond existing solutions.
• Strong problem-solving with broad business impact.
• Proficiency in Microsoft Office (Word, Excel, Outlook).
• Highly organized with an inquisitive mindset.
• Strong math skills for percentages and ratios.

Responsibilities

• Review and update equipment, maintenance, and calibration procedures.
• Complete complex documentation (instrument qualifications, change controls, deviations) accurately.
• Provide support for laboratory operations ensuring compliance and inspection readiness.
• Coordinate qualification activities and author/update qualification documents.
• Support instrument data archiving and tracking change controls; manage deviations.
• Ensure IQ/OQ/PQ protocols are SPV by client personnel.
• Confirm that all qualification activities are documented.
• Test plans executed and results documented to meet acceptance criteria.
• Apply chromatography principles to interpret chromatogram abnormalities.
• Ensure programs and procedures are followed per client scope.
• Manage contractor specifications and performance.
• Verify compliance with safety, regulatory and company policies.
• Show initiative to develop new methods; lead by example.
• Communicate complex ideas effectively and influence stakeholders.

Skills

HPLC/UPLC knowledge

MS Office

Math skills

Problem solving

Organizational skills

Education

High School Diploma or GED

Tools

HPLC/UPLC instrumentation

Job description

CBRE's Full Spectrum Lab Services unit seeks an experienced professional to support pharmaceutical research and development environments. You will manage instrument qualification activities, update procedures, and help ensure inspection readiness in highly regulated settings.

Coordinate qualification tasks, author and update qualification documents, and support data archiving and change controls. You will verify IQ/OQ/PQ protocols, ensure documentation accuracy, and help drive compliant outcomes